Philips Oral Healthcare, LLC
Form 483 issued May 8, 2026 · Bothell, Washington
- Inspection
- Apr 29 – May 8, 2026
- Investigator
- Brian R. Hendricks
- Observations
- 3
- Pages
- 7
- FEI number
- 1000126901
In short: On May 8, 2026, FDA issued a Form 483 with 3 observations to Philips Oral Healthcare, LLC in Bothell, Washington (FEI 1000126901) after an inspection that ran Apr 29 – May 8, 2026. The investigator was Brian R. Hendricks. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.10 (requirements for a quality management system).
At a glance
2 of 3 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.10 (2×) · 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
One or more processes for risk management in product realization have…
- 03
Design and development verification was not adequately performed in accordance with planned and documented arrangements to…
This inspection in context
Brian R. Hendricks
6 documents · 2024–2026
Cites 820.10 (requirements for a quality management system) more than any other section. Most of their documents are for sites in Washington.
The firmPhilips Oral Healthcare, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Philips Oral Healthcare, LLC?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.10 (requirements for a quality management system). The opening words of each observation are shown on this page.
Who inspected Philips Oral Healthcare, LLC?
Brian R. Hendricks is named on this Form 483, for the inspection of Apr 29 – May 8, 2026. Each investigator has a profile showing what they cite most.
When was Philips Oral Healthcare, LLC inspected by FDA?
The inspection ran Apr 29 – May 8, 2026, and the Form 483 is dated May 8, 2026.
How do I get the full Form 483 for Philips Oral Healthcare, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.